A Phase III trial of intensity modulated radiation therapy for pelvic and/or para-aortic nodes and intra-cavitary brachytherapy combined with chemotherapy for stage IIb-IVa cervical cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17013683

Enrollment

Unknown

Registered

2017-12-04

Start date

2016-06-01

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Interventions

Control group:Standard pelvic chemo-radiotherapy

Experimental group:Pelvic chemo-radiohtherapy concomitant with Para-aortic nodal regional IMRT

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. FIGO 2008 stage IIB, IIIA, IIIB or IVA disease; 2. Aged 18 to 65 years; 3. ECOG performance status 0 - 2; 4. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervixWBC >=3.0 x 10^9/L and ANC >=2.0 x 10^9/L; Platelets >=100 x 10^9/L; Bilirubin =60ml/min or >=50 ml/min by EDTA creatinine clearance; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any previous pelvic radiotherapy; 2. Previous chemotherapy for this tumor; 3. Pelvic and/or para-aortic lymph node >=1cm, and para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive or >=15mm short axis diameter on CT); 4. Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria; 5. Evidence of distant metastases; 6. Prior diagnosis of Crohns disease or ulcerative colitis; 7. Patients with other invasive malignancies; 8. Patients who are pregnant or lactating; 9. Any contraindication to the use of cisplatin chemotherapy; 10. Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; 11. HIV positive.

Design outcomes

Primary

Measure	Time frame
Overall survival;	—

Secondary

Measure	Time frame
Recurrence survival rate;	—

Countries

China

Contacts

Public ContactXiaohua Wu

Fudan University Shanghai Cancer Center

docwuxh@hotmail.com+86 64175590-81006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026